EUREKA, MO—The formulation for RotoMetrics‘ RotoRepel Rx nonstick rotary die treatment has undergone a U.S. Food and Drug Administration (FDA) regulatory compliance review, migration testing, and toxicological safety assessment. RotoRepel Rx is safe for intended use in conversion of parts, devices and labels. Additionally, RotoRepel Rx is compliant with U.S. FDA food contact regulations. RotoRepel Rx is filed with the U.S. Food and Drug Administration under Master File for Devices (MAF) #2975.
“We are extremely excited for new RotoRepel Rx to be on file with the US FDA,” said Keith Laakko, VP of marketing for RotoMetrics. “RotoRepel Rx opens the door for customers to use our innovative no-stick and enhanced die performance treatment in new applications. Customers have access to our filing as a portion of a 510(k) submission to the FDA. This is great news for customers converting parts, devices and labels in medical and other related industries. Additionally, our formulation is compliant with food contact regulations, so it is safe for intended use in food contact applications for packaging, parts and labeling.”
RotoRepel Rx offers exclusive nonstick and enhanced press performance benefits, including:
- Presses run faster
- Reduction of adhesive build-up on all adhesive types
- Significant improvement in press uptime
- Less die damage because of less handling
- Dies are easier to clean and return to inventory ready to run
- Fewer missing labels and a reduction of blocking during rewind
- Significant reduction in static at the die station